Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults
3 de mayo de 2011 actualizado por: Pfizer
A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After First Time Administration Of Ascending Single Oral Doses To Healthy Adult Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
80
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06511-5473
- Pfizer Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
- Women of non-childbearing potential only.
- Japanese subjects muct have 4 Japanese grandparents who were born in Japan.
Exclusion Criteria:
- Previous antibiotic use within 14 days prior to dosing.
- Use of antibiotics during hospitalization within 90 days prior to dosing.
- History of sensitivity to macrolides or ketolides.
- Presence of clinically significant eye conditions (other than corrective lenses).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cohorte 1
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75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
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|
Experimental: Cohorte 2
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75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
Experimental: Cohorte 3
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
Experimental: Cohorte 4
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
Experimental: Cohorte 5
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
Experimental: Cohorte 6
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
Experimental: Cohorte 7
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
Experimental: Cohort 8
Japanese volunteers, low dose previously tested (based on PK)
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75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
Experimental: Cohort 9
Japanese volunteers, intermediate dose previously tested (based on PK)
|
75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
|
Experimental: Cohort 10
Japanese volunteers, high dose previously tested (based on safety)
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75 mg oral dose (prepared solution) given once
placebo to match 75 mg oral dose (prepared solution), given once
150 mg oral dose (prepared solution) given once
placebo to match 150 mg oral dose (prepared solution), given once
300 mg oral dose (prepared solution) given once
placebo to match 300 mg oral dose (prepared solution), given once
750 mg oral dose (prepared solution) given once
placebo to match 750 mg oral dose (prepared solution), given once
1000 mg oral dose (prepared solution) given once
placebo to match 1000 mg oral dose (prepared solution), given once
1250 mg oral dose (prepared solution) given once
placebo to match 1250 mg oral dose (prepared solution), given once
1500 mg oral dose (prepared solution) given once
placebo to match 1500 mg oral dose (prepared solution), given once
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Evaluation of safety and tolerability of PF-04287881 after single oral dose.
Periodo de tiempo: Daily up to discharge, follow-up 7-10 days after dosing
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Daily up to discharge, follow-up 7-10 days after dosing
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Pharmacokinetics of PF-04287881 after a single oral dose.
Periodo de tiempo: Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.
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Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2008
Finalización primaria (Actual)
1 de diciembre de 2009
Finalización del estudio (Actual)
1 de diciembre de 2009
Fechas de registro del estudio
Enviado por primera vez
12 de noviembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
17 de noviembre de 2008
Publicado por primera vez (Estimar)
18 de noviembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de mayo de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
3 de mayo de 2011
Última verificación
1 de mayo de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B0581001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre PF-04287881
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PfizerTerminadoInfecciones del Tracto RespiratorioEstados Unidos
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PfizerTerminado
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University of FloridaTerminadoSíntomas gastrointestinales | Frecuencia de heces | Tiempo de tránsito gastrointestinalEstados Unidos
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PfizerTerminado
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PfizerTerminado
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PfizerTerminado